Endovascular TreatmentNCT06078917
Endovascular Treatment for AIS in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry
An observational study of Endovascular Treatment, run by Wen-huo Chen at 1 site in China.
Trial summary
To investigate the Endovascular Treatment difference between Chinese city and country hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endovascular Treatment
- How many people
- 1,196 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Jul 2023
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischemic stroke caused by anterior circulation intracranial large vessel occlusion and receiving EVT were included.
Who may be able to join
- age ≥18 years; (2) diagnosis of AIS caused by imaging-confirmed intracranial LVO, including isolated cervical internal carotid artery or tandem occlusion, intracranial internal carotid artery, middle cerebral artery (M1/M2), anterior cerebral artery (A1/A2); (3) initiation of any type of EVT, including mechanical thrombectomy, emergent angioplasty via balloon or/and stent; (4).Onset-to-presentation time with 24 hours; (5).Patients whose onset-to-presentation time surpass 6 hours should had CTP and fulfill with DAWN[6] or DEFUSE's[7] criteria.
Who cannot join
- Without follow up outcome; (2) posterior circulation stroke;(3)no evidence of LVO on angiogram.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endovascular Treatment for Acute Ischemic Stroke in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry
To investigate the Endovascular Treatment difference between Chinese city and country hospital.
Read the detailed description
Endovascular Treatment for AIS in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry is an academic , independent, pragmatic , prospective , multicenter , observational registry study . Patients with acute ischemic stroke caused by anterior circulation intracranial large vessel occlusion and receiving EVT were included. Patients were divided into primary stroke center (county hospital) and senior stroke center (city hospital) groups. Acute ischemic stroke (AIS) workflow, EVT procedural details and clinical outcome were compared in two groups. The aim of the study was to explore the EVT difference in Chinese city and county hospital.
- Conditions
- Endovascular Treatment
- Keywords
- Endovascular Treatment, acute ischemic stroke
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Rankin Scale score at 90 days
The range of the modified Rankin Scale is from 0 to 6. A higher score indicates a worse outcome.
0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6-Dead.
Measured: 90 days
Baseline CT/magnetic resonance and CT angiography/magnetic resonance angiography imaging, digital subtraction angiography
Radiological assessment included ASPECTS ，location of occlusion site, presence of underlying ICAS ，or exist microcatheter "First-Pass Effect".
Measured: 90 days
Successful reperfusion
Successful reperfusion was defined as eTICI ≥2b
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Nov 2021
- Primary completion31 Dec 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,196 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Wen-huo Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wen-huo Chen, Zhangzhou Municipal Hospital
- Investigators
- Wen-huo Chen, bachelor, Principal investigator, Zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078917
- Sponsor's protocol ID
- A "Real world" study-ETERNITY
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment for Acute Ischemic Stroke in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry
- ClinicalTrials.gov ID
- NCT06078917
- Acronym / sponsor ID
- A "Real world" study-ETERNITY
- Conditions
- Endovascular Treatment
- Keywords
- Endovascular Treatment, acute ischemic stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,196 participants (actual)
- Lead sponsor
- Wen-huo ChenUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the Endovascular Treatment difference between Chinese city and country hospital.
Detailed description
Endovascular Treatment for AIS in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry is an academic , independent, pragmatic , prospective , multicenter , observational registry study . Patients with acute ischemic stroke caused by anterior circulation intracranial large vessel occlusion and receiving EVT were included. Patients were divided into primary stroke center (county hospital) and senior stroke center (city hospital) groups. Acute ischemic stroke (AIS) workflow, EVT procedural details and clinical outcome were compared in two groups. The aim of the study was to explore the EVT difference in Chinese city and county hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke caused by anterior circulation intracranial large vessel occlusion and receiving EVT were included.
Key inclusion criteria (1 listed)
- age ≥18 years; (2) diagnosis of AIS caused by imaging-confirmed intracranial LVO, including isolated cervical internal carotid artery or tandem occlusion, intracranial internal carotid artery, middle cerebral artery (M1/M2), anterior cerebral artery (A1/A2); (3) initiation of any type of EVT, including mechanical thrombectomy, emergent angioplasty via balloon or/and stent; (4).Onset-to-presentation time with 24 hours; (5).Patients whose onset-to-presentation time surpass 6 hours should had CTP and fulfill with DAWN[6] or DEFUSE's[7] criteria.
Key exclusion criteria (1 listed)
- Without follow up outcome; (2) posterior circulation stroke;(3)no evidence of LVO on angiogram.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The modified Rankin Scale score at 90 days
Time frame: 90 days
The range of the modified Rankin Scale is from 0 to 6. A higher score indicates a worse outcome. 0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6-Dead.
Baseline CT/magnetic resonance and CT angiography/magnetic resonance angiography imaging, digital subtraction angiography
Time frame: 90 days
Radiological assessment included ASPECTS ，location of occlusion site, presence of underlying ICAS ，or exist microcatheter "First-Pass Effect".
Successful reperfusion
Time frame: 90 days
Successful reperfusion was defined as eTICI ≥2b
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-huo Chen, bachelor principal investigator
Zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endovascular Treatment, run by Wen-huo Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modified Rankin Scale score at 90 days (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.